Does Menopause Matter?
The purpose of this study is to follow a woman’s progression through menopause in order to examine the effects on health related quality of life and use of health care resources, and to understand how women are using alternative therapies.
Description
Menopause affects every woman as she ages, yet every woman’s experience is different. We are seeking to enroll 720 women from the University of Pittsburgh’s Division of General Internal Medicine Outpatient practice (GIMO) at all stages of menopause (pre-, peri-, and post-menopausal), between 40 and 65 years old. They will be followed for 5 years as they progress through menopause.
Women will complete yearly questionnaires during their usual doctor’s visit (or by phone or online if necessary) regarding general health, menopause and menopausal symptoms, health related quality of life, traditional and alternative therapy use, social support, and attitudes towards menopause and aging.
We will combine this information with information from women’s medical charts to look at how menopause and health related quality of life impact the use of health care resources. Additionally, some women may be asked about the use of health care resources, such as doctor’s visits, hospitalizations and lab tests.
Status: Active, not recruiting (N/A). Started on December 1st, 2004.
Enrollment: 720 subjects
Study Type: Observational
Study Design:
- Observational Model: Cohort
- Time Perspective: Prospective
Conditions:
Interventions:
Eligibility
Inclusion Criteria:
Women ages 40-65
Patients in the University of Pittsburgh General Internal Medicine Oakland Practice
Able to complete the Functional Assessment Screening Tablet (a touch-screen survey)
Exclusion Criteria:
- Refusal to participate
- Gender
Female
- Mininum Age
40 Years
- Maximum Age
65 Years
- Healthy Volunteers
Accepts Healthy Volunteers
Resources
Source: University of Pittsburgh
Authority: United States: Federal Government
Locations
-
UPMC General Internal Medicine Oakland
Pittsburgh
Pennsylvania
15213
United States
Officials
Rachel Hess, MD, MSc (Principal Investigator, UPMC General Internal Medicine-Oakland)
Sponsors
University of Pittsburgh (Lead Sponsor)
National Institute on Aging (NIA) (Collaborator)
National Center for Complementary and Alternative Medicine (NCCAM) (Collaborator)
References
Hlatky MA, Boothroyd D, Vittinghoff E, Sharp P, Whooley MA; Heart and Estrogen/Progestin Replacement Study (HERS) Research Group. Quality-of-life and depressive symptoms in postmenopausal women after receiving hormone therapy: results from the Heart and Estrogen/Progestin Replacement Study (HERS) trial. JAMA. 2002 Feb 6;287(5):591-7.
PMID: 11829697.
Check for Full TextAvis NE, Ory M, Matthews KA, Schocken M, Bromberger J, Colvin A. Health-related quality of life in a multiethnic sample of middle-aged women: Study of Women's Health Across the Nation (SWAN). Med Care. 2003 Nov;41(11):1262-76.
PMID: 14583689.
Check for Full TextGambacciani M, Ciaponi M, Cappagli B, Monteleone P, Benussi C, Bevilacqua G, Genazzani AR. Effects of low-dose, continuous combined estradiol and noretisterone acetate on menopausal quality of life in early postmenopausal women. Maturitas. 2003 Feb 25;44(2):157-63.
PMID: 12590012.
Check for Full TextAlbertazzi P, Purdie D. The nature and utility of the phytoestrogens: a review of the evidence. Maturitas. 2002 Jul 25;42(3):173-85. Review.
PMID: 12161041.
Check for Full Text
Links
None.
- Date Verified
- September 1st, 2011
- First Received
- September 9th, 2011
- Last Changed
- September 9th, 2011
Information obtained from ClinicalTrials.gov on September 12, 2011. Link to the current ClinicalTrials.gov record.
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